United States Patent 9,592,253: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,592,253, titled "Extended use zirconium silicate compositions and methods of use thereof," is a significant patent in the pharmaceutical industry, particularly for the treatment of hyperkalemia. This patent is associated with the drug Lokelma, which is owned by AstraZeneca Pharmaceuticals LP. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent US9592253B1 pertains to zirconium silicate compositions, specifically those with a lead content below 0.6 ppm. These compositions are designed for extended use, particularly in the treatment of hyperkalemia, a condition characterized by elevated potassium levels in the blood[2][4].
Key Components
- Zirconium Silicate: The patent focuses on the development and use of zirconium silicate, a microporous material that can bind potassium ions.
- Lead Content: The compositions have a strict limit on lead content, ensuring they are safe for medical use.
- Manufacturing Process: The patent includes methods for manufacturing these zirconium silicate compositions, emphasizing the importance of maintaining low lead levels throughout the process[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention:
- Composition Claims: These claims specify the chemical composition of the zirconium silicate, including the limit on lead content and the presence of other ions such as potassium, sodium, and calcium[1].
- Method Claims: These claims describe the methods of manufacturing the zirconium silicate compositions, including the processes for ensuring the low lead content and the cation exchange methods involved[1].
Independent Claim Length and Count
The scope of the patent can also be analyzed through metrics such as independent claim length and count. These metrics are important in assessing the breadth and clarity of the patent claims. Generally, narrower claims with fewer words and fewer independent claims are associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Related Patents
The patent US9592253B1 is part of a larger family of patents related to Lokelma. Other patents in this family include:
- US8877255: Microporous zirconium silicate for the treatment of hyperkalemia.
- US10300087: Extended use zirconium silicate compositions and methods of use thereof.
- US10695365: Microporous zirconium silicate for the treatment of hyperkalemia[2][4].
Patent Expiration Dates
The expiration dates of these patents are crucial for understanding the timeline for generic competition:
- US9592253B1: Expected to expire on October 14, 2035.
- US10300087: Expected to expire on October 14, 2035.
- US8877255: Expected to expire on October 22, 2033[2][4].
Legal Activities and Challenges
The patents protecting Lokelma have been subject to various legal activities, including patent term extensions, withdrawals of applications, and oppositions. These activities can affect the patent's expiration date and the potential for generic launch. For example, recent activities include patent term extension certificates and responses to requests for information under 37 CFR 1.750[2].
Impact on Generic Competition
Generic Launch Date
The estimated generic launch date for Lokelma is October 14, 2035, based on the expiration of the key patents. However, this date can be influenced by ongoing legal activities and challenges to the patents[2][5].
International Patent Protection
While the focus here is on U.S. patents, Lokelma is also protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points in regions with weaker patent protection[2].
Conclusion
The United States Patent 9,592,253 is a critical component of the intellectual property portfolio for Lokelma, a drug used to treat hyperkalemia. The patent's scope, defined by its claims and manufacturing methods, ensures the safety and efficacy of zirconium silicate compositions. The broader patent landscape, including related patents and their expiration dates, is vital for understanding the timeline for generic competition and the potential for market entry.
Key Takeaways
- Patent Scope: The patent covers zirconium silicate compositions with low lead content and specifies manufacturing methods.
- Claims: The patent includes composition and method claims that define the invention.
- Related Patents: Part of a larger family of patents protecting Lokelma.
- Expiration Dates: Key patents expire between 2032 and 2035.
- Legal Activities: Ongoing legal activities can affect patent expiration dates and generic launch timelines.
- Generic Competition: Estimated generic launch date is October 14, 2035, subject to changes based on legal activities.
FAQs
What is the primary use of the zirconium silicate compositions described in US9592253B1?
The primary use is for the treatment of hyperkalemia, a condition characterized by elevated potassium levels in the blood.
What is the significance of the lead content limit in the patent?
The limit ensures the compositions are safe for medical use by keeping the lead content below 0.6 ppm.
How many patents protect the drug Lokelma in the United States?
Lokelma is protected by 15 U.S. drug patents, with 14 currently active and one expired.
What is the estimated generic launch date for Lokelma?
The estimated generic launch date is October 14, 2035, based on the expiration of key patents.
Can the expiration date of the patent change due to legal activities?
Yes, the expiration date can be influenced by ongoing legal activities such as patent term extensions, withdrawals of applications, and oppositions.
Sources
- US9592253B1 - Extended use zirconium silicate compositions and methods of use thereof - Google Patents
- Lokelma patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Sodium zirconium cyclosilicate - DrugBank
- Generic Lokelma Availability - Drugs.com
